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PharmacoEconomics May 2023Economic evaluations of vaccines should accurately represent all relevant economic and health consequences of vaccination, including losses due to adverse events...
Accounting for Adverse Events Following Immunization in Economic Evaluation: Systematic Review of Economic Evaluations of Pediatric Vaccines Against Pneumococcus, Rotavirus, Human Papillomavirus, Meningococcus and Measles-Mumps-Rubella-Varicella.
OBJECTIVES
Economic evaluations of vaccines should accurately represent all relevant economic and health consequences of vaccination, including losses due to adverse events following immunization (AEFI). We investigated to what extent economic evaluations of pediatric vaccines account for AEFI, which methods are used to do so and whether inclusion of AEFI is associated with study characteristics and the vaccine's safety profile.
METHODS
A systematic literature search (MEDLINE, EMBASE, Cochrane Systematic Reviews and Trials, Database of the Centre for Reviews and Dissemination of the University of York, EconPapers, Paediatric Economic Database Evaluation, Tufts New England Cost-Effectiveness Analysis Registry, Tufts New England Global Health CEA, International Network of Agencies for Health Technology Assessment Database) was performed for economic evaluations published between 2014 and 29 April 2021 (date of search) pertaining to the five groups of pediatric vaccines licensed in Europe and the United States since 1998: the human papillomavirus (HPV) vaccines, the meningococcal vaccines (MCV), the measles-mumps-rubella-varicella (MMRV) combination vaccines, the pneumococcal conjugate vaccines (PCV) and the rotavirus vaccines (RV). Rates of accounting for AEFI were calculated, stratified by study characteristics (e.g., region, publication year, journal impact factor, level of industry involvement) and triangulated with the vaccine's safety profile (Advisory Committee on Immunization Practices [ACIP] recommendations and information on safety-related product label changes). The studies accounting for AEFI were analyzed in terms of the methods used to account for both cost and effect implications of AEFI.
RESULTS
We identified 112 economic evaluations, of which 28 (25%) accounted for AEFI. This proportion was significantly higher for MMRV (80%, four out of five evaluations), MCV (61%, 11 out of 18 evaluations) and RV (60%, nine out of 15 evaluations) compared to HPV (6%, three out of 53 evaluations) and PCV (5%, one out of 21 evaluations). No other study characteristics were associated with a study's likelihood of accounting for AEFI. Vaccines for which AEFI were more frequently accounted for also had a higher frequency of label changes and a higher level of attention to AEFI in ACIP recommendations. Nine studies accounted for both the cost and health implications of AEFI, 18 studies considered only costs and one only health outcomes. While the cost impact was usually estimated based on routine billing data, the adverse health impact of AEFI was usually estimated based on assumptions.
DISCUSSION
Although (mild) AEFI were demonstrated for all five studied vaccines, only a quarter of reviewed studies accounted for these, mostly in an incomplete and inaccurate manner. We provide guidance on which methods to use to better quantify the impact of AEFI on both costs and health outcomes. Policymakers should be aware that the impact of AEFI on cost-effectiveness is likely to be underestimated in the majority of economic evaluations.
Topics: Child; Humans; Chickenpox; Cost-Benefit Analysis; Streptococcus pneumoniae; Human Papillomavirus Viruses; Rotavirus; Neisseria meningitidis; Mumps; Papillomavirus Infections; Vaccination; Immunization; Measles; Rotavirus Vaccines; Rubella
PubMed: 36809673
DOI: 10.1007/s40273-023-01252-z -
The Pediatric Infectious Disease Journal Nov 2021The safety and immunogenicity of M-M-RII (measles, mumps and rubella virus vaccine live, Merck & Co., Inc., West Point, PA)-the only combined measles, mumps and rubella...
Evaluation of the Safety and Immunogenicity of M-M-RII (Combination Measles-mumps-rubella Vaccine): Clinical Trials of Healthy Children and Adults Published Between 2010 and 2019.
BACKGROUND
The safety and immunogenicity of M-M-RII (measles, mumps and rubella virus vaccine live, Merck & Co., Inc., West Point, PA)-the only combined measles, mumps and rubella vaccine licensed for use in the United States-were previously reported in pre- and postlicensure clinical trials conducted from 1988 to 2009. M-M-RII continues to be evaluated as a comparator in clinical trials of other vaccines. Here, we review safety and efficacy data from more recent clinical trials of M-M-RII.
METHODS
We performed a systematic literature review of trials using M-M-RII published from 2010 to 2019.
RESULTS
In the 15 studies that met the inclusion criteria, a total of 12,032 subjects were vaccinated: 7667 persons received a first dose only, 2137 participated in 2-dose studies (128 received 1 dose and 2009 received both) and 2063 received a single dose of M-M-RII as their second dose. Dose number was not specified for 165 participants, ≥6 years old, in 2 studies in which a single dose of M-M-RII was administered. Similar to previous reports, M-M-RII was well tolerated and immunogenic when administered alone or concomitantly with other routinely recommended vaccinations. The most common adverse events included transient injection site pain and fever. Serious adverse events were extremely rare, with only 4 probable or potential vaccine-related events reported among the 12,032 participating subjects.
CONCLUSIONS
In trials published from 2010 to 2019, M-M-RII continued to be safe and immunogenic in all age groups studied. These data, along with the results of earlier trials, indicate that the performance of the vaccine has been consistent across more than 30 years of postlicensure studies.
Topics: Antibodies, Viral; Clinical Trials as Topic; Humans; Immunization Schedule; Immunogenicity, Vaccine; Measles; Measles-Mumps-Rubella Vaccine; Mumps; Research Report; Rubella; Vaccination; Vaccines, Combined
PubMed: 34310506
DOI: 10.1097/INF.0000000000003273 -
International Journal of Pediatric... Jul 2020
Review
PubMed: 32283428
DOI: 10.1016/j.ijporl.2020.110024 -
Tuberkuloz Ve Toraks Jun 2022The first application of modern non-invasive mechanical ventilation (NIV) can be traced back to over 30 years ago when a patient suffering from Duchenne Muscular...
The first application of modern non-invasive mechanical ventilation (NIV) can be traced back to over 30 years ago when a patient suffering from Duchenne Muscular Dystrophy was successfully ventilated. Since then, the use of NIV has been on the rise throughout the world. Although a very modern and safe therapy, complications during its application are inevitable. In addition to some well-known complications, others have described more rare entities. In this article, we described such rare complications as pneumoperitoneum, pneumocephalus, parotitis, gastric perforation, and barotrauma. The purpose of this review was to describe unusual complications of NIV, their prevalence, and the mechanisms by which such complications arise. We performed a clinical review by searching PubMed, Embase, and Cochrane libraries with Mesh terms: 'non-invasive mechanical ventilation', 'high-flow nasal cannula', 'rare complication', 'unusual complication', and 'unexpected complication'. These terms were cross-referenced with other keywords: 'pneumoperitoneum', 'parotitis', 'pneumocephalus', 'gastric insufflation', and 'barotrauma'. We included 26 research papers. When applying mechanical ventilation, it is necessary to have a strong knowledge of the mechanics of the device as well as familiarity with the complications that may occur during its use, including less common ones. Prompt and effective treatment of such complications is required, as well as careful consideration of the potential causes of such events, during the application of NIV or HFNC.
Topics: Cannula; Humans; Noninvasive Ventilation; Oxygen Inhalation Therapy; Respiration, Artificial; Treatment Outcome
PubMed: 35785884
DOI: 10.5578/tt.20229810 -
Laryngoscope Investigative... Jun 2021To evaluate salivary gland chemodenervation with botulinum toxin in chronic parotid sialadenitis.
OBJECTIVE
To evaluate salivary gland chemodenervation with botulinum toxin in chronic parotid sialadenitis.
METHODS
Patients who underwent parotid gland chemodenervation for chronic sialadenitis due to duct stenosis refractory to siaendoscopy were reviewed (case series). Additionally, a systematic review of the literature on botulinum toxin injection for chronic parotid sialadenitis was performed. Inclusion criteria included studies containing original data on botulinum toxin injections in patients with chronic sialadenitis symptoms.
RESULTS
Sialadenitis symptoms from 10 patients with 13 affected parotid glands were examined. All had duct stenosis diagnosed on sialendoscopy, refractory sialadenitis symptoms, and received parotid onabotulinum toxin injection(s) (median dose 65U). Of patients with 3-month follow-up, 78% reported significant improvement in symptoms. Mean Chronic Obstructive Sialadenitis Symptoms (COSS) Score improved at 3 months post-injection (47-25.9, = .039) with significant reduction in gland pain frequency and gland swelling severity. No patients had a facial nerve paralysis or increased xerostomia. With the systematic review, 518 abstracts were reviewed and 11 studies met inclusion criteria and included case series or case reports with a total of 40 patients treated with botulinum toxin for chronic parotitis. Thirty-four out of a total of 35 patients in the studies (97%) reported complete (9, 26%) or partial (25, 71%) improvement in sialadenitis symptoms with minimal complications.
CONCLUSION
Parotid gland chemodenervation with botulinum toxin is a minimally invasive treatment option for symptomatic chronic sialadenitis refractory to medical treatment or sialendoscopy. Botulinum toxin injections alleviate gland pain and swelling associated with salivary obstruction and provide an alternative to parotidectomy for recurrent sialadenitis.Level of evidence: 4.
PubMed: 34195360
DOI: 10.1002/lio2.558 -
Human Vaccines & Immunotherapeutics Dec 2022M-M-R® (M-M-R II) is routinely used in many countries at 12-15 months with a second dose at 4 to 6 years of age. However, the vaccine may need to be administered at...
M-M-R® (M-M-R II) is routinely used in many countries at 12-15 months with a second dose at 4 to 6 years of age. However, the vaccine may need to be administered at other ages due to delays in the immunization schedule or in certain situations such as outbreaks or international travel. A systematic literature review was conducted to evaluate efficacy, immunogenicity and safety of M-M-R II among 6- to 11-month-olds and persons ≥7 years of age. A search for randomized controlled trials (RCTs) was conducted in 2019 including Medline, Embase and Cochrane CENTRAL. Only one study reported seroconversion rates after one dose in infants at 9 months of age: 87.4% (measles), 92.3% (mumps), and 91.2% (rubella); no safety data were reported. Seven studies reported immunogenicity and safety data for M-M-R II at ≥7 years of age. Seroconversion rates ranged from 96%-100% (measles), 65%-100% (mumps), and 91%-100% (rubella). Rates of selected adverse events ranged from 5.2%-8.7% for fever (≥38°C or ≥38.1°C), 2%-33.3% for injection site reactions, and 0.4% for measles/rubella-like rash (one study). No efficacy studies were found. This literature review identified RCTs with evidence to support that M-M-R II is immunogenic and well tolerated in individuals ≥7 years of age.
Topics: Aged, 80 and over; Antibodies, Viral; Antigens, Viral; Humans; Immunization Schedule; Infant; Measles; Measles-Mumps-Rubella Vaccine; Mumps; Rubella; Vaccines, Combined
PubMed: 34128759
DOI: 10.1080/21645515.2021.1933874 -
The Journal of Dermatological Treatment Dec 2021Warts can be difficult to treat and progressing to chronic and resistant disease. Several studies have reported the successful application of mumps-measles-rubella (MMR)... (Meta-Analysis)
Meta-Analysis
Intralesional measles-mumps-rubella is associated with a higher complete response in cutaneous warts: a systematic review and meta-analysis of randomized controlled trial including GRADE qualification.
INTRODUCTION
Warts can be difficult to treat and progressing to chronic and resistant disease. Several studies have reported the successful application of mumps-measles-rubella (MMR) vaccine resulting in clearance of warts immunomodulation and induction of immune system.
METHODS
We performed a comprehensive search on the role of intralesional MMR in warts from several electronic databases. Complete response is defined as complete clearance of warts lesion.
RESULTS
There were a total of 425 subjects from five studies. Intralesional injection of MMR was associated with an increased complete response (OR 9.43 [5.78, 15.37], < .001; : 5%, = .38). Subgroup analysis on patients receiving injection for every 2 weeks for a maximum of five injections revealed an OR of 11.70 [6.40, 21.38], < .001; : 20%, = .29. Patients receiving intralesional MMR were associated with a lower partial response (OR 0.54 [0.33, 0.88], = .01; : 0%, = .66). Intralesional MMR was associated with a reduced no-response (OR 0.16 [0.06, 0.43], < .001; : 69%, = .01). Funnel plot analysis for complete response was asymmetrical, indicating the risk of publication bias. There were statistically significant small-study effects for intralesional MMR on complete response upon analysis using Harbord's test ( = .047). Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment showed that intralesional MMR injection has high level of certainty (quality of evidence) for complete response in warts with an absolute increase of 505 per 1000.
CONCLUSION
Intralesional MMR injection was associated with a higher complete response and lower no-response with a high level of certainty.
Topics: Humans; Injections, Intralesional; Measles; Measles-Mumps-Rubella Vaccine; Mumps; Randomized Controlled Trials as Topic; Rubella; Warts
PubMed: 31985307
DOI: 10.1080/09546634.2020.1716931